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The CrossCLIP™ Implant System is manufactured from nickel titanium alloy (ASTM F2063-12 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants). The implants are one-piece devices designed to be implanted into the bones of the hand or foot for fragment osteotomy fixation and joint arthrodesis. The staple legs have barb-type features on the inside and outside of the legs to resist pullout. The implants are available in a range of sizes similar to the predicate devices.

The instruments needed for implantation consist of an implant inserter, drill/reamer guide, drill/reamer and provisional fixation pin. The implant inserter is considered a Class II instrument. All other instruments are Class I.

The design features of the CrossCLIP™ Implant System are summarized below:

Implant Grade Nitinol (ASTM F2063-12) o
O Various sizes to accommodate patient anatomy
o One piece construction
Barbs to resist pull-out O
O Single use, sterile packaged instruments

AI/ML Overview

The provided text is a 510(k) summary for the CrossCLIP™ Implant System, which is a medical device used for bone fixation. However, it does not contain the detailed information necessary to answer all sections of your request regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the document is a premarket notification from the FDA, confirming substantial equivalence to predicate devices, rather than a detailed scientific study report. It mentions "design verification analysis" and "performance testing" but does not provide the specifics of these tests as requested.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

Cannot be fully provided. The document states: "Results of the design verification activities met the required acceptance criteria." and "The completed analysis has shown that the performance of the subject device is substantially equivalent to the predicate devices." However, it does not list the specific acceptance criteria or the reported device performance metrics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be provided. The document refers to "design verification analysis" and "performance testing" but does not specify sample sizes, data provenance, or whether the study was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable / Cannot be provided. This type of information is typically related to diagnostic or imaging device performance where expert review establishes ground truth. The CrossCLIP™ Implant System is a physical bone fixation device, and its performance testing would likely involve biomechanical or material properties testing, not expert interpretation of diagnostic data. The document does not mention any expert review process for establishing ground truth related to its performance studies.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable / Cannot be provided. Similar to point 3, adjudication methods are typically used in diagnostic studies involving inter-reader variability. This document does not suggest such a method was used for the device's performance testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This document describes a physical medical device (bone fixation implant), not an AI algorithm or a diagnostic aid. Therefore, an MRMC study related to AI assistance for human readers is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Cannot be provided definitively. Based on the nature of the device (bone fixation implant), "ground truth" for performance testing would typically involve objective biomechanical measurements (e.g., pullout strength, compression force, fatigue life) compared against established standards (like ASTM F2063-12) or predicate device performance. However, the document does not explicitly state the type of ground truth used, only that performance was "verified against the predicate device" and "ASTM F2063-12 Standard Specification."

8. The sample size for the training set

Not applicable. The device is a physical implant, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established

Not applicable. As above, no training set for a machine learning model is involved.

Summary of available information from the document:

Device Name: CrossCLIP™ Implant System
Intended Use: Hand and foot bone fragment osteotomy fixation and joint arthrodesis.
Regulatory Status: Substantially equivalent to predicate devices (K070031 and K124045).
Performance Testing Mentioned: "Design verification analysis" and "Performance Testing" against predicate device (K070031 – MemoMetal Memory Staples MemoClip – For Fusion; MemoMetal Technologies) and ASTM F2063-12 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants.
Conclusion of Performance Testing: "The completed analysis has shown that the performance of the subject device is substantially equivalent to the predicate devices."

To answer your request comprehensively, a detailed study report or technical documentation outlining the specific tests performed (e.g., mechanical testing protocols), their results, and the acceptance criteria used would be required, which is not present in this FDA 510(k) clearance letter.

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